What the evidence shows
What the records say the classes mean. Outlook, May 2025: The FDA has determined that the BLA is a Class 2 review, which results in a six-month review period from the date of resubmission.
8-K · May 15, 2025 Outlook, June 2026: a Class 1 resubmission with a PDUFA date and decision expected within 60 days of FDA’s receipt of the resubmission
8-K · Jun 1, 2026. CorMedix, in March and April 2023, set out what it expected to decide the class: Given that no new data would be contained in this resubmission, provided no additional site inspections are required, the Company believes this may be classified as a Class 1 submission with a 60-day review.
8-K · Mar 3, 2023 and As the submission will contain new manufacturing information, the Company expects it to be classified as a Class 2 resubmission with a 6-month review.
8-K · Apr 26, 2023 These are the companies' statements; none of these records quotes an FDA definition.
Replimune: Class II, then Class 1. we resubmitted the BLA on October 9, 2025
10-K · Jun 29, 2026; The PDUFA date set by the FDA is April 10, 2026 based on a Class II resubmission timeline.
8-K · Oct 20, 2025 The review ended with the second CRL issued by the FDA on April 10, 2026
10-K · Jun 29, 2026. Then: On June 26, 2026 we announced the FDA accepted the BLA resubmission as a Class 1 resubmission with an action date of August 2, 2026. The FDA also stated that they would convene an advisory committee meeting in late July 2026.
10-K · Jun 29, 2026 The committee voted 10 to 3
8-K · Jul 31, 2026, and the August 8-K announced that the FDA has granted accelerated approval for TUDRIQEV
8-K · Aug 7, 2026.
Outlook: Class 2, then Class 1. we resubmitted the BLA application for ONS-5010/LYTENAVA on February 27, 2025
10-K · Dec 19, 2025; The FDA set a PDUFA goal date of August 27, 2025.
8-K · May 15, 2025 The 10-K: received a subsequent CRL on August 27, 2025
10-K · Dec 19, 2025. After a further resubmission and letter, the appeal decision set the class of the next one: As indicated in the formal decision, it is anticipated that this will be a Class 1 resubmission
8-K · May 26, 2026. The company announced the resubmission of its Biologics License Application (BLA)
8-K · Jun 1, 2026 on June 1, 2026. Not in this record: an FDA action on it.
CorMedix: Class 2, twice. In 2022: The Agency considers the resubmission as a complete, Class 2 response with a six month review cycle.
8-K · Mar 28, 2022 That review ended in A second Complete Response Letter (CRL)
8-K · Aug 9, 2022. In 2023, as the company had expected, the resubmission was again Class 2: a complete, Class 2 response with a six-month review, and has assigned a Prescription Drug User Fee Act (PDUFA) target action date of November 15, 2023
8-K · Jun 21, 2023. On November 15, 2023, we announced that the FDA approved the new drug application
10-K · Mar 5, 2026.
Aldeyra: Class 2, extended. Following submission on June 16, 2025, the NDA was accepted for review as a “complete class 2 response” by the FDA on July 16, 2025, with a target PDUFA action date of December 16, 2025.
8-K · Dec 16, 2025 A late submission changed the clock: the field trial report was considered a major amendment to the NDA by the FDA
8-K · Dec 16, 2025, and The extended PDUFA target action date is March 16, 2026.
8-K · Dec 16, 2025 The review ended with the March 16, 2026 Complete Response Letter
8-K · Sep 29, 2026. How did a field trial left out of the June 2025 resubmission end up in the FDA's review?
Across the four records, each Class 2 review described here ended in either a Complete Response Letter (Replimune 2026, Outlook 2025, CorMedix 2022, Aldeyra 2026) or an approval (CorMedix 2023). The two Class 1 resubmissions here both followed a repeat letter: Replimune's after alignment with the FDA on a path forward, Outlook's after an appeal.
Follow the thread
- What happens after a second FDA Complete Response Letter?CorMedix's Class 2 resubmission and approval
- How did two programs move forward after repeat FDA letters without running a new trial?Replimune's Class 1 resubmission
Questions this raises
Comparing these records raises new questions. They are not yet investigated.
- Did the class of a resubmission match how quickly a decision followed in these records?
- What did each company include in a resubmission it expected to be Class 1?
The documents, by date
The passages quoted
CorMedix Form 8-K, filed March 28, 2022
The Agency considers the resubmission as a complete, Class 2 response with a six month review cycle.Open at the source →
CorMedix Form 8-K, filed August 9, 2022
A second Complete Response Letter (CRL) was received from the FDA stating that the DefenCath NDA cannot be approved until deficiencies recently conveyed to the contract manufacturing organization (CMO) and the supplier of the active pharmaceutical ingredient (API) heparin during inspections are resolved to the satisfaction of FDA. There were no other deficiencies related to DefenCath cited in the CRL, and the Company expects that resolution of the site-specific compliance deficiencies will clear a pathway for FDA to approve the DefenCath NDA.Open at the source →
CorMedix Form 8-K, filed March 3, 2023
CMO 1 + API 1: This scenario potentially remains the fastest pathway to NDA resubmission and approval, provided FDA concurs that CMO 1 has remediated its compliance deficiencies and that the DMF for API 1 can be utilized prior to full resolution of the existing warning letter. CorMedix hopes to obtain guidance from FDA on these two important issues in a Type A meeting. The Company intends to resubmit the application as soon as possible following FDA’s positive guidance on these two issues. Given that no new data would be contained in this resubmission, provided no additional site inspections are required, the Company believes this may be classified as a Class 1 submission with a 60-day review.Open at the source →
CorMedix Form 8-K, filed April 26, 2023
Based on guidance from FDA, CorMedix will resubmit the NDA with manufacturing data generated at CMO 1 and utilizing both the existing source of heparin API (“API 1”) as well as a new supplier of Heparin API (“API 2”). The Company has completed the validation of the manufacturing process using API 2, and believes all batches have met product specifications. Data for submission are currently available and resubmission is targeted for mid-May following receipt of final Type A meeting minutes. As part of validation of manufacturing with this API, the Company will be adding a 3 mL single-dose vial to its 5 mL commercial presentation to meet market preferences and demand. As the submission will contain new manufacturing information, the Company expects it to be classified as a Class 2 resubmission with a 6-month review.Open at the source →
CorMedix Form 8-K, filed June 21, 2023
today announced that the resubmission of the New Drug Application (NDA) for DefenCath has been accepted for filing by the U.S. Food and Drug Administration (FDA). The Agency considers the resubmission as a complete, Class 2 response with a six-month review, and has assigned a Prescription Drug User Fee Act (PDUFA) target action date of November 15, 2023.Open at the source →
Outlook Therapeutics Form 8-K, filed May 15, 2025
The FDA has determined that the BLA is a Class 2 review, which results in a six-month review period from the date of resubmission. The FDA set a PDUFA goal date of August 27, 2025.Open at the source →
Replimune Form 8-K, filed October 20, 2025
The PDUFA date set by the FDA is April 10, 2026 based on a Class II resubmission timeline.Open at the source →
Aldeyra Therapeutics Form 8-K, filed December 16, 2025
The extended PDUFA target action date is March 16, 2026.Open at the source →
Aldeyra Therapeutics Form 8-K, filed December 16, 2025
The CSR, which had been previously submitted to the Investigational New Drug (IND) file for reproxalap, was submitted to the NDA the same day of the meeting and was considered a major amendment to the NDA by the FDA. Per the FDA’s earlier request during the NDA review, the safety data from the field trial was submitted to the NDA on August 21, 2025. The CSR has been reviewed by the FDA under the IND.Open at the source →
Aldeyra Therapeutics Form 8-K, filed December 16, 2025
Following submission on June 16, 2025, the NDA was accepted for review as a “complete class 2 response” by the FDA on July 16, 2025, with a target PDUFA action date of December 16, 2025.Open at the source →
Outlook Therapeutics Form 10-K, filed December 19, 2025
Upon receipt of the full month 3 efficacy and safety results for NORSE EIGHT, we resubmitted the BLA application for ONS-5010/LYTENAVA on February 27, 2025 and received a CRL on August 28, 2025.Open at the source →
Outlook Therapeutics Form 10-K, filed December 19, 2025
we resubmitted the BLA application for ONS-5010/LYTENAVA on February 27, 2025, and received a subsequent CRL on August 27, 2025. Following a September 2025 Type A meeting with the FDA, we resubmitted the ONS-5010/LYTENAVA BLA on November 3, 2025 and received a PDUFA goal date of December 31, 2025 from the FDA.Open at the source →
CorMedix Form 10-K, filed March 5, 2026
On November 15, 2023, we announced that the FDA approved the new drug application (“NDA”) for DefenCath, an antimicrobial catheter lock solution (“CLS”) (a formulation of taurolidine 13.5 mg/mL, and heparin 1000 USP Units/mL) indicated to reduce the incidence of catheter-related bloodstream infections (“CRBSI”) in adult patients with kidney failure receiving chronic hemodialysis through a central venous catheter (“CVC”). We launched DefenCath commercially in April 2024 in the inpatient setting and July 2024 in the outpatient hemodialysis setting, and it is the largest contributor to our net sales.Open at the source →
Outlook Therapeutics Form 8-K, filed May 26, 2026
In its formal response, OND determined that the results of the NORSE TWO trial, together with confirmatory evidence including NORSE EIGHT, natural history, and mechanistic and pharmacodynamic data, establish substantial evidence of effectiveness for LYTENAVA™ for the treatment of nAMD. The response directs the Division and OSM to work with Outlook Therapeutics to reach an agreement on final labeling. As indicated in the formal decision, it is anticipated that this will be a Class 1 resubmission with a PDUFA date and decision expected within 60 days of FDA’s receipt of the resubmission.Open at the source →
Outlook Therapeutics Form 8-K, filed June 1, 2026
The FDR decision directed the Division of Ophthalmology and Office of Specialty Medicine to work with Outlook Therapeutics to focus on reach ing an agreement on final product labeling. Additionally, as indicated in the formal decision, this will be a Class 1 resubmission with a PDUFA date and decision expected within 60 days of FDA’s receipt of the resubmission.Open at the source →
Outlook Therapeutics Form 8-K, filed June 1, 2026
today announced the resubmission of its Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for ONS-5010/LYTENAVA™ for the treatment of neovascular age-related macular degeneration (nAMD).Open at the source →
Replimune Form 10-K, filed June 29, 2026
Following the second CRL issued by the FDA on April 10, 2026 for the Company's RP1 BLA for the treatment of advanced melanoma, the Lead Plaintiff filed a second amended complaint in the class action that addresses the second CRL.Open at the source →
Replimune Form 10-K, filed June 29, 2026
On June 26, 2026 we announced the FDA accepted the BLA resubmission as a Class 1 resubmission with an action date of August 2, 2026. The FDA also stated that they would convene an advisory committee meeting in late July 2026.Open at the source →
Replimune Form 10-K, filed June 29, 2026
Following the evaluation of FDA feedback and minutes from the type A meeting, we resubmitted the BLA on October 9, 2025.Open at the source →
Replimune Form 8-K, filed July 31, 2026
The committee then voted 10 to 3, on the question: "Are the efficacy results from IGNYTE evaluable and clinically meaningful?"Open at the source →
Replimune Form 8-K, filed August 7, 2026
today announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval for TUDRIQEV TM (vusolimogene oderparepvec-wtpg), previously referred to as RP1, in combination with nivolumab for the treatment of adults with unresectable advanced cutaneous melanoma who experienced disease progression on an anti-PD-1 antibody-based regimen.Open at the source →
Aldeyra Therapeutics Form 8-K, filed September 29, 2026
The FDRR, which is expected to be reviewed by the FDA’s Office of New Drugs (OND), is designed to appeal the March 16, 2026 Complete Response Letter that denied approval of a New Drug Application (NDA) for reproxalap for the treatment of dry eye disease. Submission of the FDRR and a meeting with the OND are expected in the fourth quarter of 2026.Open at the source →